HealthCCS

System, X-ray, Tomography, Computed

Zebra Medical Vision Ltd.

The following data is part of a premarket notification filed by Zebra Medical Vision Ltd. with the FDA for Healthccs.

Pre-market Notification Details

Device IDK172983
510k NumberK172983
Device Name:HealthCCS
ClassificationSystem, X-ray, Tomography, Computed
Applicant Zebra Medical Vision Ltd. Shefayim Commercial Center PO Box 25 Shefayim,  IL 6099000
ContactMatan Neeman
CorrespondentFlair Bar
Zebra Medical Vision Ltd. Shefayim Commercial Center PO Box 25 Shefayim,  IL 6099000
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-27
Decision Date2018-06-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290018016008 K172983 000

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